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Abstract/Syllabus:
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Ethics of Human Subject Research
Spring 2005
Vaccine trials are governed by research ethics, such as informed consent and privacy.
Instructor
Holly Taylor
Offered By
Health Policy and Management
Description
Ethics of Human Subject Research (2 credits) is offered by the Department of Health Policy and Management and the Distance Education Division, Johns Hopkins Bloomberg School of Public Health and The Phoebe R. Berman Bioethics Institute, Johns Hopkins University. The course introduces students to the ethics of human subject research. Ethical theory and principles are introduced, followed by a brief history of research ethics. Topics covered in lectures and moderated discussions include informed consent for research participation, role and function of institutional review boards, just selection of research subjects, ethical aspects of study design, and privacy and confidentiality. Student evaluation will be based on participation in moderated discussions, an informed consent exercise and written case analysis.
Syllabus
Please note that this course does not fulfill the NIH or the JHSPH requirement for training in the responsible conduct of research.
Course Description
Ethics of Human Subject Research (2 credits) is offered by the Department of Health Policy and Management and the Distance Education Division, Johns Hopkins Bloomberg School of Public Health and The Phoebe R. Berman Bioethics Institute, Johns Hopkins University. The course introduces students to the ethics of human subject research. Ethical theory and principles are introduced, followed by a brief history of research ethics. Topics covered in lectures and moderated discussions include informed consent for research participation, role and function of institutional review boards, just selection of research subjects, ethical aspects of study design, and privacy and confidentiality. Student evaluation will be based on participation in moderated discussions, an informed consent exercise and written case analysis.
Course Objectives
After completion of this course, you will be able to:
- Discuss the principles of bioethics and how these principles should be applied the ethical conduct of human subject research.
- Identify, define, and analyze ethical issues in the context of human subject research.
- Identify, through case studies, ethical issues that arise in different contexts and begin to reason through an appropriate course of action.
- Draft informed consent forms.
Readings
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary . Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003.
This text can be ordered through:
Matthews Johns Hopkins Medical Book Center
1830 East Monument Street
Baltimore, MD 21205 USA
410.955.3931
800.266.5725
410.955.0576 Fax
http://www.cbamatthews.com/jhmedbook/
Course Format
The first week of the course will focus on ethical theory and a review of historical and contemporary issues in research ethics. Weeks two through six will cover substantive issues relevant to the conduct of human subject research. During weeks seven and eight students will choose whether to be engaged in an in-depth exploration of research with children or ethical issues in genetics research.
Course Topics
- Ethical theory and principles
- History of research ethics
- Contemporary issues in research ethics
- Balancing the benefits and harms of participation in research
- Ethical issues in study design
- Informed consent in research
- Institutional Review Boards
- Selection of research participants
- Ethical issues in vaccine research
Schedule
| Introduction to Ethical Analysis |
Lecture |
| Cases and Codes |
Lecture |
| Assessment of Risks and Benefits |
Lecture |
| Respect for Persons and Informed Consent |
Lecture |
| Informed Consent and Cultural Relativism |
Lecture |
| Introduction to Institutional Review Boards (IRBs) |
Lecture |
| Protection and Access |
Lecture |
| Justice in Research Ethics: International Issues |
Lecture |
| Research Ethics and Human Rights |
Lecture |
| Coercion and Undue Inducement in Research: Money and Other Offers |
Lecture |
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Further Reading:
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Readings
Reading List (37KB) This document contains a comprehensive list of all readings, including those for the live chat sessions.
Textbooks
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary . Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003.
| Introduction to Ethical Analysis |
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report"(1979)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 33-38.
Ezekiel Emanuel, David Wendler, and Christine Grady. 2000. What Makes Clinical Research Ethical? JAMA 283(20): 2701-11.
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| Cases and Codes |
Henry K. Beecher, "Ethics and Clinical Research" (1966)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 16-20.
Allan Brandt, "Racism and Research: The Case of the Tuskegee Syphilis Study"
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003 , pp. 20-23.
Vanessa Northington Gamble, "Under the Shadow of Tuskegee: African Americans and Health Care", American Journal of Public Health, 1997; 87(11): 1773-1778.
"The Nuremberg Code" (1949)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, p. 29.
World Medical Association, "Declaration of Helsinki" (1964, rev. 2000)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 30-32.
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| Assessment of Risks and Benefits |
Charles Weijer, Gary Goldsand and Ezekiel Emanuel. "Protecting Communities in Research: Current Guidelines and Limits of Extrapolation." (1999)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 340-341.
Charles Weijer and Ezekiel Emanuel. "Protecting Communities in Biomedical Research." (2000)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 342-343.
Neal Dickert and Christine Grady. "What's the Price of a Research Subject? Approaches to Payment for Research Participation." (1999)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 179-183.
Ruth Grant and Jeremy Sugarman. 2004. Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy 29(6): 717-738.
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| Respect for Persons and Informed Consent |
Robert J. Levine, "Consent Issues in Human Research" (1995)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 197-201.
Franz J. Ingelfinger, "Informed (But Uneducated) Consent" (1972)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 202-203.
Jay Katz, "Human Experimentation and Human Rights" (1993)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 210-213.
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| Informed Consent and Cultural Relativism |
Nicholas A. Christakis. "Ethics are Local: Engaging Cross-Cultural Variation in Ethics Research." (1992)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 358-363.
Macklin R, "International Research and Ethical Imperialism," Chapter 8 in Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine, New York: Oxford University Press (1999): 188-217
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| Introduction to Institutional Review Boards (IRBs) |
Harold Edgar and David J. Rothman, "The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation" (1995)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 436-440.
Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Code of Federal Regulations , Title 45, Part 46 "Protection of Human Subjects" (1991)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 39-55.
Charles Weijer, Stanley H. Shapiro, Abraham Fuks, Kathleen Cranley Glass and Myriam Skrutkowska, "Monitoring Clinical Research, An Obligation Unfulfilled" (1995)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 425-429.
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| Protection and Access |
Dresser, Rebecca, "Wanted. Single, White Male for Medical Research" (1992)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 166-171.
Charles Weijer and Robert A. Crouch, "Why Should we Include Women and Minorities in Randomized Controlled Trials?" (1999)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 171-174.
The National Bioethics Advisory Commission. "Research Involving Persons with Mental Disorders that May Affect Decision-Making Capacity."
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 229-233.
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| Justice in Research Ethics: International Issues |
Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), "International Ethical Guidelines for Biomedical Research Involving Human Subjects" (2002)
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 56-80.
Richard Love and Norman Fost. "Ethical and Regulatory Challenges in a Randomized Controlled Trial of Adjuvant Treatment in Vietnam."
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003, pp. 363-367.
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| Research Ethics and Human Rights |
Christopher Beyrer and Nancy Kass. Human rights, Politics and Research Ethics Review. Lancet 2002; 360(9328):246-51. |
| Coercion and Undue Inducement in Research: Money and Other Offers |
No readings assigned. |
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